AE-Preferred Term | Dose-Optimization Phase | |
---|---|---|
 | 6 to 9 year olds | 10 to 12 year olds |
 | (n = 48) | (n = 81) |
 | n (%) | n (%) |
Any AE | 43 (89.6) | 67 (82.7) |
Abdominal pain upper | 8 (16.7) | 12 (14.8) |
Affect lability | 7 (14.6) | 6 (7.4) |
Anorexia | 5 (10.4) | 2 (2.5) |
Decreased appetite | 23 (47.9) | 38 (46.9) |
Headache | 9 (18.8) | 13 (16.0) |
Insomnia | 17 (35.4) | 18 (22.2) |
Irritability | 7 (14.6) | 14 (17.3) |